Respectful Insolence

Alternative medicine and breast cancer

After the three posts that I recently did about vaccination have garnered well over 250 comments between the three of them (and still counting), I thought it might be time to switch topics. As important as they are, I don’t want this blog to become all vaccines all the time. (After all, look what happened to the blog SupportVaccination.org. It’s a long story that I’ll have to tell you sometime; but suffice it to say that the blog no longer exists.) Quite frankly, seeing the same old fallacies being repeated over and over again by antivaxers does get tiresome after a while. After all, how many times can you rebut the same things over and over again?

Wait a minute.

Isn’t that what I do on this blog (rebut the same fallacies over and over and over again), be they claims from creationists, alties, or Holocaust deniers?

Never mind. Rebutting the same logical fallacies over and over again seems to be the lot of a skeptic. It’s what I do on this blog. Keep reading, and I’ll try to continue to make it entertaining.

Fortunately for your (and my) edification, there recently appeared in the American Journal of Surgery a paper that actually looks at what happens to women who decide to opt for “alternative” therapy rather than conventional therapy. Given my specialty and interest in evidence-based medicine and applying EBM to “alternative” therapies, I’d be truly remiss if I didn’t comment. So here we go, and here’s the paper:

Chang et al (2006). Outcomes of breast cancer in patients who use alternative therapies as primary treatment. Am. J. Surg. 192:471-473.

Here’s the abstract:

BACKGROUND: Some breast cancer patients opt for alternative treatments in place of conventional treatments. The lack of published data on the outcome of this strategy may contribute to this trend. METHODS: A chart review was performed of breast cancer patients who refused or delayed standard surgery, chemotherapy, and/or radiation therapy. Prognosis was calculated for recommended and actual therapy. RESULTS: Thirty-three patients were included in the analysis. Of 11 patients who initially refused surgery, 10 developed disease progression. Of 3 patients who refused adequate nodal sampling, 1 developed nodal recurrence. Of 10 patients who refused local control procedures, 2 developed local recurrences and 2 died of metastatic disease. By refusing chemotherapy, 9 patients increased their estimated 10-year mortality rate from 17% to 25%. CONCLUSIONS: Alternative therapies used as primary treatment for breast cancer are associated with increased recurrence and death. Homeopathy instead of surgery resulted in disease progression in most patients. These data may aid patients who are considering alternative therapies.

This study is interesting to me because it’s the first one that I can recall that has explicitly looked at the outcomes of patients who chose “alternative” therapies as their primary treatment. There are lots of studies out there looking at alternative medicine use in cancer patients, but these mainly look at patients who use it in addition to conventional therapy (i.e., as “complementary” therapy). It’s rare for a study to look at outcomes in patients using alternative medicine as their primary treatment. Because this is a retrospective study, it’s not without its flaws, but, because it would be highly unethical to do a randomized, double-blinded trial looking at this question, retrospective studies are the best we can do, even with their flaws. This study does have one strength, though, compared to most such studies, and that it the patient population. It comes from a community practice, not an academic medical center. Consequently, it can be viewed as more representative of the “real” world situation than many studies done in academic medical centers, where the patient population may be self-selected as people as either motivated enough to seek out tertiary care centers or sick enough that their community surgeons and oncologists refer them.

One thing that is rather fascinating is the variety of alternative therapies that the study population opted for, including coral calcium, coenzyme Q10, herbs, dietary therapy, high dose vitamins, mushrooms, chelation therapy, poison hemlock (I’m still scratching my head over that one, particularly given how alties so frequently lambaste chemotherapy as “poison”), and a variety of unspecified therapies. At least there were no examples of coffee enemas that I could see. In any case, because of the sheer variety of therapies used and the low number of patients using each individual one that, as the authors put it, it was not possible to “identify particular alternative modalities that were particularly ineffective.”

Who says scientific papers don’t occasionally have sarcasm in them?

Basically, the study identified 47 breast cancer patients who opted for alternative therapy, but followup information was only available for 33. These were divided into patients who refused surgical treatment altogether; patients who delayed appropriate surgical treatment to pursue alternative treatments; patients who refused adequate sampling of the lymph nodes; patients who refused procedures to ensure adequate local control (additional surgery and/or radiation therapy); and patients who refused chemotherapy. I’m going to concentrate on patients who refused or delayed surgery.

Of patients who refused surgery, none of the six patients identified were Stage IV (metastatic disease) at initial diagnosis. However, five out of these six patients who returned to the surgeons doing the study had progressed to stage IV, with a median time of followup of 14 months, with one death within a year. That’s pretty amazing, given that two of these patients were Stage I upon initial presentation. There were also five patients identified who initially refused surgery in favor of alternative medicine, all of whom were Stage II or III. The median time between diagnosis and surgery was 37 months. All five demonstrated progression of their disease, with three progressing to Stage IV disease and one of these dying of metastatic disease. Thus, 10/11 patients who refused surgery experienced significant disease progression.

Not surprisingly, patients who declined chemotherapy or hormonal therapy fared better because, as I’ve explained before, for operable breast cancer, the single most efficacious intervention is surgery, and it is not that uncommon for patients with even fairly large tumors to be “cured” with surgery alone. Indeed, as I discussed before, the benefits of chemotherapy are fairly modest in many cases. In a small number of patients, it was difficult to quantify the effect of choosing alternative medicine over conventional chemotherapy, but the authors were able to estimate that the relative risk of death in 10 years in those who refused chemotherapy was 1.54; i.e., a 54% higher chance of dying within 10 years compared to those treated with conventional medicine.

As a retrospective study, this study has several flaws, mainly the inability to compare directly a group treated with only alternative medicine with a group treated with conventional medicine. But, because it would be unethical to try to do a randomized study on this issue because of concerns over observing patients falling below the standard of care (as the authors put it), retrospective studies are the best we’ll be able to do for now. What will be needed are studies looking at larger numbers of patients, particularly so that associations can be inferred about which particular forms of alternative therapy are associated with worse outcomes than others. From my perspective, the reason for worse outcomes in patients who choose alternative medicine over conventional is almost certainly from the delay in treatment. In other words, my best guess is that most alternative therapies are probably not causing a worse outcome (although it’s possible that some are, due to toxicity), but rather are simply ineffective, allowing the cancer to progress in essence untreated.

It’s also important to point out that, among cancers, breast cancer tends to be one of the slower-growing, and therefore more forgiving–not always, but usually. Delays in treatment of a few weeks usually don’t make much, if any difference, in outcome. If it were otherwise, doing immediate reconstruction would be more difficult because the time constraints in coordinating the schedules of the breast surgeon and the plastic surgeon would be much more tight. Consequently, seeing such a decrease in survival in the patients who opted for alternative therapy, particularly such that it is so obvious in even small numbers of patients, suggests that the alternative therapies used by patients in this study are at best worthless and at worst harmful. Moreover, it suggests to me that the results of reliance on such unproven treatments for more aggressive cancers would be even more potentially disastrous. My hope is that this study (1) serves as a warning to breast cancer patients considering opting for alternative therapies in preference to conventional therapy and (2) spurs more research in this area to identify which therapies may actually be worse than useless.

Comments

  1. #1 Elizabeth
    September 25, 2006

    Thanks for posting this; it was **extremely** interesting.

  2. #2 speedwell
    September 25, 2006

    Thank you for this. My mom was one of those who delayed treatment in order to pursue alternative therapies for her uncomplicated lump. By the time she actually consented to the conventional therapy, her cancer had spread. She underwent radiation twice and went into “remission” twice, then the cancer reappearerd in a place under her collarbone that had already been irradiated, so they could not do it again (just repeating what I heard; I don’t know if this is true). After that any care she could receive was just an increasingly desperate attempt to make her feel better as she died.

    I may be wrong, but I think if she had agreed to aggressive treatment at the start, she might have been a success story today. She wasn’t that old and she did manage to fight it off twice. The initial choice of therapy might possibly have made the entire difference.

  3. #3 Abel Pharmboy
    September 25, 2006

    A fabulous analysis of a study that would be impossible (unethical, as you note) to do prospectively. I note particularly, “Homeopathy instead of surgery resulted in disease progression in most patients.”

    Medical oncologists I know who work in multidisciplinary settings (i.e., with radiation oncology and surgeons like you) have been spending much more time carefully considering each case to only give chemotherapy to those who stand to benefit and using less toxic anti-hormonal therapies (tamoxifen and aromatase inhibitors) more often as adjuncts to surgery.

    But what is amazing to me as a pharmacologist, and no surprise to you as a surgeon, is just how effective surgery alone is in many types of breast cancer. Perhaps those who wish to forego chemotherapy might care think of surgery as the “other alternative medicine”?

  4. #4 quitter
    September 25, 2006

    Orac,
    I’ll have to add anti-vaccination BS to my list of Denialist arguments which are basically just arguments used against science when one doesn’t have data, facts, or a leg to stand on.

    You may find it a timesaver when they come out of the woodwork in the future to just say you won’t accept denialist arguments and dismiss them out of hand.

  5. #5 Robster
    September 25, 2006

    Excellent article. My PhD research was in breast and lung cancer, and I work with a regional breast cancer survivor support group. This will go straight into my presentation.

    Speedwell, I’m sorry about your mother. Take care.

  6. #6 Shygetz
    September 25, 2006

    A topic came up at work, and I was wondering if anyone here knows the answer. Have these “alternative” therapies ever been tested in prospective trials using animal models of disease? Or are they powered primarily by human psychic energy, so animal models are irrelevant?

  7. #7 Steve
    September 25, 2006

    Speedwell,

    I’m also sorry to hear about your mother. It’s tough losing someone to cancer, and I can’t even imagine how it must feel when you think it might have been avoided.

    Without knowing any details, I think it is probably true that your mother could not be retreated with radiation after the recurrence. The normal tissue surrounding a tumor can only take so much radiation and usually a patient will be treated right up to that limit. Even years later, it can be impossible to retreat an area without going over that limit and causing unacceptable radiation damage.

    Once again, sorry for your loss.

  8. #8 Darby
    September 25, 2006

    The test group seems small to me, so I have to ask – how many “regular” patients go by while a group of almost 50 alternative-primary patients accumulates?

  9. #9 Sid Schwab
    September 25, 2006

    Forgive me if I’ve mentioned this before: our local paper ran a three-day series, breathlessly (and credulously) describing the bravery and take-control of a woman who’d been cured by conventional methods of cancer in one breast a few years earlier. She developed a new one in the opposite breast, and didn’t what those “poisons” again. So she refused conventional therapy and followed alternative diets, meditation, and the bogus ministrations of a license-revoked MD who made potions of her urine (the paper helpfully provided contact info.) This was front page stuff with nice sidebars for three days running. The news of her death, around a year later, was buried on page 6, section four. At the time I’d left messages for the reporter, saying she was doing a disservice to women, but she never returned my calls.

  10. #10 TheBrummell
    September 25, 2006

    I’m trying to think of how one could collect data for a larger-scale, similar study.

    I know doctors in general are pretty much overworked (insert irrelevant anecdote about your friend’s nephew’s former roommate who is now a big-shot Hollywood plastic surgeon here), but I wonder how difficult it would be for a researcher to ask doctors to please write down some basic information every time a patient refuses “conventional” treatment for (any) cancer.

    There are probably privacy and ethics issues here that I’m unaware of – but I get the impression that refusal or delay of treatment in order to pursue “alternatives” is pretty common – so big sample sizes are out there, waiting to be analysed.

    The idea would be to collect basic survival / progression information for as wide a range of both locations and cancer types as possible, simply by looking at what happens when people refuse treatment. Given the significant effects the authors of this study were able to find using 33 patients divided into multiple categories (say goodbye to some degrees-of-freedom, there), I’d say you wouldn’t need to track a huge number of patients.

  11. #11 Mandy
    September 26, 2006

    Could you please tell us what happenned to SupportVaccination.org? Pretty please? I thought it was a great blog.

  12. #12 Amy Alkon
    September 26, 2006

    Excellent piece — as always. I have to tell you, reading your site has inspired me to create a directive for care (in case I’m in a coma or something) that explicitly states that I do not believe in “alternative medicine,” and only want the best, data-driven, science-based care.

  13. #13 coracle
    September 26, 2006

    There’s something I don’t get though, in the abstract there is the line Homeopathy instead of surgery resulted in disease progression in most patients. Yet table 1 (Alternative therapies taken by each group of patients)doesn’t list homeopathy. What’s going on?

  14. #14 Anna
    September 26, 2006

    Oh, please tell us what happened with supportvaccination.org. I’ve heard some fairly ugly things from anti-vaxers about why the blog author pulled it, and I’d love to know the other side of the story.

  15. #15 Paul
    September 26, 2006

    Readers of this Blog might be interested to know that there new regulations coming into force in the UK allow homeopathic remedies to be sold alongside real medicine without having to provide any scientific evidence of efficacy. They can now be labelled “For the treatment of X”, without providing any evidence that they help treat or cure condition X.

    At a time when pharmaceutical companies are finally being forced to make the results of all clinical trials public this is a major step in the wrong direction.

    Sense about Science have prepared a statement of objection to the The Medicines for Human Use (National Rules for Homeopathic Products) Regulations 2006. Go to their website at http://www.senseaboutscience.org.uk/index.php/site/project/86
    and add your support to their effort to have this new regulation changed.

  16. #16 Robster
    September 26, 2006

    Coracle, homeopathy was likely used interchangably with alternative medicine. Just a thought.

  17. #17 Hyperion
    September 26, 2006

    **but I wonder how difficult it would be for a researcher to ask doctors to please write down some basic information every time a patient refuses “conventional” treatment for (any) cancer.**

    One word: HIPAA

    Ok, it’s an acronym, but the point still stands. Obviously it will vary from situation to situation, but in general I would think that the HIPAA privacy provisions might make this rather difficult.

    Besides, if a patient is refusing their physician’s medical advice, I’m not sure how willing they’re going to be to hand over personal information to him for the kind of scientific research that most of them abhor. And just as the Cherrix and Wernicke (sp?) parents have been much less willing to discuss their alternative treatment as it fails to help, I’d imagine that many of the patients who might initially consent to divulge such information might retract that consent later if their chosen alternative treatment turns out to be fairly unhelpful.

    That being said, future reporting requirements related to SGR reform and pay-for-performance initiatives could potentially make it easier to collect this sort of data, albeit without much identifying information that could be used to track the patient’s future treatment and prognosis.

  18. #18 epador
    September 26, 2006

    Lord, I just saw one who after her bilateral complete mastectomies for invasive lobular Ca 7 years ago opted against tamoxifen “after looking at all the alternatives” but still smoking half a pack a day.

    While one could argue against post treatment tamoxifen in this setting, it never fails to amaze me how these folks can KEEP SMOKING after one cancer! I guess taking “natural” vitamins and etc. is the same as smoking a natural plant material?

  19. #19 Ruth
    September 26, 2006

    I once had an office that faced the parking lot of a major cancer center. Ambulatory patients receiving chemo would come outside to smoke. This only stopped when smoking was banned from the whole campus and not just the clinic itself. Tobacco is hard to give up, glad I never started.

  20. #20 Orac
    September 26, 2006

    Tobacco is an addiction that is very hard to quit for physiological and psychological reasons. I’m damned glad I never tried the stuff, because I don’t know if I would have the persistence and fortitude that it takes to quit.

  21. #21 Andrew Dodds
    September 27, 2006

    Epador -

    I suspect that it’s the ‘Lightening doesen’t strike twice’ reasoning – people thinking that they won’t get lung cancer because they already have breast cancer..

    Having said that and as a ex-smoker, I often find that the exclusion of smokers goes well beyond any sort of evidence – witness banning smoking from a whole campus. There does seem a certain mean-spirtedness about making a terminal cancer patient go through nicotine withdrawl on to of everything else.

  22. #22 coracle
    September 27, 2006

    Robster,

    It’s a possibility I suppose. Unfortunately, homeopathy is a fairly unique barking mad type of altmed and it’s hard to use this evidence to debunk it if the authors can’t get it right.

  23. #23 Dan R.
    September 28, 2006

    FYI…

    HIPAA would not stop this type of study. Most HIPAA policies I’ve seen allow for sharing of medical information for research purposes to IRB identified / cleared investigators, or for the research purposes of the treating physician.

    As long as an IRB (a kind of ethics committee) has cleared the study, it usually wouldn’t be a problem.

  24. #24 Rob
    September 29, 2006

    Excellent post; i was also interested in the lack of ‘significant’ disease progression after refusing chemo. Too bad; I want to do research into tamoxifen resistant br ca; but if the cure rates are that good w/ surgury alone, i don’t see this as a high funding priority for the NIH.

  25. #25 Emily
    October 2, 2006

    It’s not so much the retrospective chart review that bothers me but the lack of controls. I think to do a better job with this study topic one would need a bigger sample size and match women who underwent standard therapy as a primary treatment, by age and disease stage.

  26. #26 Seth Manapio
    October 23, 2006

    “Tobacco is an addiction that is very hard to quit for physiological and psychological reasons. I’m damned glad I never tried the stuff, because I don’t know if I would have the persistence and fortitude that it takes to quit.”

    ———-

    Allow me to speak as an ex-smoker without much self-control and no great willpower or persistence to speak of.

    Quitting smoking (after 15 years of a pack a day of non-filters) was one of the easiest things I’ve ever done. It took an instant to do (it can’t take longer). It didn’t require any special therapy, patches, or anything else. It just isn’t nearly as hard as people say it is, they just don’t want to quit: they enjoy smoking and they intend to keep doing it until they die.

    Look at it this way… it is infinitly easier NOT to smoke than it is TO smoke.

  27. #27 Fazilah
    January 22, 2007

    i found out i have breast cancer two months ago and i have been delaying surgery but opt for alternative treatment. my cancer is 2cm long and the doctor said i’m in stage II. science can only go so far and then comes God. i hope i will be able to live to tell my success story – surviving breast cancer through alternative treatment.